本文件提供了设计和执行与医疗器械相关的毒代动力学研究的原则。附件A描述了将毒代动力学研究纳入医疗器械生物学评估的考虑因素。第三版取消并取代了第二版（ISO 10993-16:2010），第二版已经过技术修订。

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.This third edition cancels and replaces the second edition (ISO 10993-16:2010), which has been technically revised.